Medtronic 207F3 Technical Manual

Freezor™ 207F1, 207F3, 207F5

Cardiac Cryoablation Catheter

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks
(“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a
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CryoConsole™, Freezor™

Explanation of symbols

Lot number

Reorder number

Use by

Sterilized using ethylene oxide

Do not reuse

Do not resterilize

Do not use if package is damaged

Package contents

Consult instructions for use

Consult instructions for use at this website: www.medtronic.com/manuals

Fragile, handle with care

Keep dry

Product documentation

Humidity limitation

Storage temperature

Transit temperature

Cardiac cryoablation catheter

Open here

Manufacturer

For US audiences only.

Caution: Federal law (USA) restricts this device to sale by or on the order of
a physician.

Date of manufacture

Single sterile barrier system with protective packaging inside

Manufactured in

Model number

3

1 Description

The Freezor Cardiac Cryoablation Catheter is a flexible, steerable catheter used to ablate and
map cardiac tissue. It is used together with the CryoConsole and related components. The tip of
the Freezor catheter reaches cryoablation temperatures when refrigerant is injected from the
CryoConsole to the tip of the catheter. The catheter tip has an integrated type T thermocouple for
temperature reading capability. The catheter is introduced into the vasculature by traditional,
minimally invasive techniques. The Freezor catheter is available in 3 models, as described in the
following table:

Model Curves available

207F1 47 mm
207F3 53 mm
207F5 58 mm

For details about the CryoConsole and how to use it with the catheter to perform cryoablation
procedures, see the CryoConsole Operator’s Manual.

1.1 Contents of package

The Freezor Cardiac Cryoablation Catheter is supplied sterile. The package contains the
following items:

• 1 Freezor Cardiac Cryoablation Catheter

• product documentation

2 Indications for use

The Freezor Cardiac Cryoablation Catheter, CryoConsole system, and related accessories are
indicated for the cryoablation of the conducting tissues of the heart in the treatment of adult and
pediatric patients over 2 years of age with atrioventricular nodal reentrant tachycardia (AVNRT).

3 Contraindications

The Freezor Cardiac Cryoablation Catheter is contraindicated in patients with the following
conditions:

• active systemic infections

• cryoglobulinemia

• intracardiac mural thrombus

• myxoma

• interatrial baffle or patch

4 Warnings and precautions

Anticoagulation therapy – Administer appropriate levels of peri-procedural anticoagulation

therapy for patients undergoing right-sided procedures. Administer anticoagulation therapy
before and after the procedure according to the hospital standards.

AV conduction – Closely monitor AV conduction during cryo energy delivery near the AV node
due to possible risk of complete atrioventricular (AV) block. Immediately terminate energy delivery
if partial or complete AV block is noted.

Biohazard disposal – Discard all used catheters and sterile components in accordance with
hospital procedures.

Cardioversion/defibrillation during ablation procedure – Disconnect the catheter’s electrical
connection prior to cardioversion/defibrillation. Failure to do so may trigger system messages
indicating a need for catheter exchange.

Catheter handling –

• Do not use excessive force to advance or withdraw the catheter, especially if resistance is
encountered.

• Use extreme care when manipulating the catheter. Lack of careful attention can result in injury
such as perforation or tamponade.

• Do not use the catheter if it is kinked, damaged, or cannot be straightened.

• Straighten the cooling segment before inserting or withdrawing the catheter.

• Do not at any time preshape or bend the catheter shaft or cooling segment. Bending or kinking
the catheter shaft may damage internal structures and increase the risk of catheter failure.
Prebending of the distal curve can damage the catheter.

• Catheter advancement should be performed under fluoroscopic guidance or other
appropriate visualization technique.

Catheter integrity – Do not use the catheter if it is kinked or damaged. If the catheter becomes
kinked or damaged while in the patient, remove it and use a new catheter. Prior to injecting, the
physician should ensure that there is no kink in the catheter.

Catheter positioning around the chordae tendineae – Avoid positioning the catheter around
the chordae tendineae, as this increases the likelihood of catheter entrapment within the heart,
which may necessitate surgical intervention or repair of injured tissues.

Coronary vessels – Cryoablation involving coronary vessels has been associated with
subsequent clinically significant arterial stenosis. Care should be taken to minimize unnecessary
contact with coronary vessels during cryoablation.

Cryoablation near prosthetic heart valves – Do not pass the catheter through a prosthetic
heart valve (mechanical or tissue). The catheter may become trapped in the valve, damaging the
valve and causing valvular insufficiency or premature failure of the prosthetic valve.

Cryoadhesion – Do not pull on the catheter, sheath, umbilical cables, or console while the
catheter is frozen to the tissue, as this may lead to tissue injury.

CryoMapping – The use of CryoMapping mode does not prevent injuries to the patient.
CryoMapping mode is used to determine if the site is appropriate for ablation.

Do not resterilize – Do not resterilize this device for the purpose of reuse. Resterilization may
compromise the structural integrity of the device or create a risk of contamination of the device that
could result in patient injury, illness, or death.

Embolism risk – Introducing any catheter into the circulatory system entails the risk of air or gas
embolism, which can occlude vessels and lead to tissue infarction with serious consequences.
Always advance and withdraw components slowly to minimize the vacuum created and therefore
minimize the risk of air embolism.

Endotoxin levels – Endotoxins may cause pyrogenic responses in patients including
inflammation and fever which can result in anaphylactic shock and death. Caution should be used
with regard to endotoxins in pediatric populations as standard endotoxin limits do not differentiate
between adult and pediatric populations.

Environmental limits – Perform cryoablation procedures only within the environmental
parameters. Operating outside these parameters may prevent the start or completion of a
cryoablation procedure.

Ethylene oxide residuals from sterilization process – Ethylene Oxide residuals remaining
after sterilization are known to cause a potential increase in a number of biological effects
including irritation, organ damage, mutagenicity, and carcinogenicity. Calculations for ethylene
oxide and ethylene chlorohydrin residuals indicate that the risk of these effects may be increased
in patients under 3.8 kg.

Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to fluids
or solvents. If these components get wet, the cryoablation system may not function properly, and
connector integrity may be compromised.

Fluoroscopy during catheter placement – The use of fluoroscopy during catheter ablation
procedures presents the potential for significant x-ray exposure to both patients and laboratory
staff. Extensive exposure can result in acute radiation injury and increased risk for somatic and

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genetic effects. Only perform catheter ablation after giving adequate attention to the potential
radiation exposure associated with the procedure, and taking steps to minimize this exposure.
Give careful consideration before using the device in pregnant women.

For single use only – This device is intended only to be used once for a single patient. Do not
reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device or create a risk of
contamination of the device that could result in patient injury, illness, or death.

Improper connection – Do not connect the cryoablation catheter to a radiofrequency (RF)
generator or use it to deliver RF energy. Doing this may cause catheter malfunction or patient
harm.

Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.

Leakage current from connected devices – Use only isolated equipment (IEC 60601-1 Type

CF equipment, or equivalent) with the CryoConsole and catheters or patient injury or death may
occur.

Other catheters, devices, or wires – Avoid catheter entanglement with other catheters,
devices, or wires. Such entanglement may necessitate surgical intervention.

Post-ablation period – Closely monitor patients undergoing cardiac ablation procedures during
the post-ablation period for clinical adverse events.

Pressurized refrigerant – The catheter contains pressurized refrigerant during operation.
Release of this gas into the circulatory system due to equipment failure or misuse could result in
gas embolism.

Qualified users – This equipment should be used only by or under the supervision of physicians
trained and/or experienced in cryoablation procedures.

Required use environment – Cryoablation procedures should be performed only in a fully
equipped facility.

RF ablation – Before powering up an RF generator or applying RF energy, disconnect the
cryoablation catheter from the CryoConsole to avoid an error message and unnecessary catheter
replacement.

Safety in magnetic resonance imaging (MRI) not evaluated – The Freezor catheter has not
been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The
safety of the Freezor catheter in the MR environment is unknown (such as any heating, migration,
or image artifact). Scanning a patient during the use of this device may result in patient injury.

Sterile package inspection – Visually inspect all sterile-barrier packaging before use. If the
device is damaged or the integrity of the sterilization barrier has been compromised, do not use
the product. Contact your Medtronic representative for return information.

Storage and transport – There is no special handling, including no special storage or transport
conditions, required for this device. Standard storage conditions are sufficient to safeguard the
device. Store the device in the original packaging at room temperature in a dry place.

System compatibility – The Medtronic cryoablation catheters, refrigerant tanks, and other
Medtronic CryoConsole components should only be used with the Medtronic CryoConsole.

5 Adverse events

Potential adverse events associated with cardiac catheter cryoablation procedures include, but
are not limited to, the following conditions:

• Access site complications (such as
hematoma, infection, thrombosis, ecchy­mosis, AV fistula, bleeding from puncture
site, hemorrhage)

• Arrhythmia (such as atrial fibrillation, atrial
flutter, tachycardia)

• Cardiac arrest

• Chest discomfort, pain or pressure

• Coronary artery spasm

• Coronary artery stenosis

• Damage to heart tissue or vasculature

• Death

• Endocarditis

• Entrapment

• Heart block, requiring permanent pace­maker

• Hemothorax

• Infection

• Perforation of venous, cardiac or surround­ing tissue

• Pericardial effusion, tamponade

• Pericarditis

• Phrenic nerve injury

• Pleural effusion

• Pneumothorax

• Pseudoaneurysm

• Pulmonary edema

• Pulmonary embolism

• Stroke

• Tissue infarction (such as myocardial in­farction or renal infarction)

• Thrombus

• Transient ischemic attack (TIA)

• Vagal nerve injury (such as gastroparesis)

• Vasovagal reaction

6 Clinical studies

Information regarding clinical studies that are applicable to Freezor are available on the Medtronic
Manual Library website:

1. Point your browser to www.medtronic.com/manuals.

2. Select the geography and language, and then search by product name for Freezor. The
catheter technical manual and any applicable studies are listed. If you do not have web
access, you can order printed copies of the clinical study summaries from your Medtronic
representative or by calling the toll-free number located on the back cover.

7 Instructions for use

This catheter has two modes, CryoMapping and CryoAblation.

During cryomapping, warmer cryo temperatures and shorter durations are used to transiently halt
electrical conduction. This allows verification of the ablation site or determines if the site is not
appropriate for ablation. The preset parameters for cryomapping are -30°C (-86°F) for a duration
of 60 s.

Because of the complexity of arrhythmia electrophysiology, four (4) different cryomapping
techniques may be used to assess catheter tip position:

• Change in the slow pathway ERP

• Change in the maximal AH interval during pacing

• Termination of the target arrhythmia

• Uninducibility of the target arrhythmia

During cryoablation, cardiac tissue is permanently ablated. The catheter has preset refrigerant
flow designed to optimize the amount of refrigerant delivered to the tip to remove as much heat as
possible. The preset duration is 240 s. There are three ways to use the different modes:

• Start and stop a CryoMapping injection if the desired effect is not seen

• Start a CryoMapping injection and proceed to CryoAblation if the desired effect is seen

• Start CryoAblation without performing CryoMapping

Following therapy delivery, effectiveness can be tested by trying to re-induce the clinical
arrhythmia.

Note: Use adequate filtering on the recording system to allow continuous monitoring of the
surface electrocardiogram (ECG) during cryo applications.

7.1 Connecting the catheter

For more detailed instructions refer to the CryoConsole Operator’s Manual.

5

1. Connect the connection box to the CryoConsole.

2. Connect the Freezor catheter to a sterile coaxial umbilical cable and a sterile electrical
umbilical cable.

3. Connect the coaxial umbilical cable to the CryoConsole and connect the electrical umbilical
cable to the connection box.

7.2 Cryomapping and cryoablation

For more detailed instructions refer to the CryoConsole Operator’s Manual.

1. Before introducing the Freezor catheter into the patient, test the deflection mechanism using
the lever on the handle to ensure it is operational.

2. Using aseptic techniques, create a vascular access with a 2.7 mm (8 Fr) minimum,
introducer or sheath and insert the Freezor catheter.

3. Choose the mode (CryoMapping or CryoAblation). At the CryoConsole screen adjust the
treatment time for cryoablation.

4. Under fluoroscopic guidance or other appropriate visualization techniques, position the tip
of the Freezor catheter at the target site, ensuring good tip contact.

Note: The Freezor catheter tip can be deflected to facilitate positioning by using the
deflection mechanism to vary tip curvature. Pulling the lever back causes the catheter tip to
bend; pushing the lever forward causes the tip to straighten.

5. Perform the application as appropriate.

6. Wait for the cryomapping or cryoablation to complete (at the end of the preset duration).
Note: At any time, the application can be stopped by pressing the Stop Current Action

button on the CryoConsole control panel or by pressing the Stop CryoAblation or Stop

CryoMapping button on the screen.
Note: Do not manipulate the device while it is frozen to the tissue.

7. Perform additional applications if required.

8. Remove the catheter from the patient.

8 Specifications

Significant physical and performance characteristics are included in the table below.

Description

Catheter shaft outer diameter 2.3 mm (7 Fr; 0.092 in)
Tip length 4 mm (0.16 in)
Curves available

207F1 47 mm (1.85 in)
207F3 53 mm (2.09 in)

207F5 58 mm (2.28 in)
Effective catheter length 108 cm (42.5 in)
Number of electrodes 4
Electrode spacing 2.5 mm (0.10 in), 5.0 mm (0.20 in), 2.5 mm

Number of thermocouples 1
Refrigerant flow 2100 ± 200 sccm
Cryomapping Pre-set at -30°C
Compatibility

Console Medtronic CryoConsole

Electrical connection cable Medtronic electrical umbilical cable (2035U,

Coaxial connection cable Medtronic coaxial umbilical cable (203CX,

Introducer sheath 2.7 mm minimum (8 Fr, 0.106 in)
Operating environmental parameters 15°C to 30°C (59°F to 86°F) at altitudes less

Sterilization single use, sterile device, ethylene oxide

a

The specific model number for the compatible CryoConsole may vary based on geography.
Contact your local Medtronic representative for additional information.

Specification

(0.10 in)

a

2035UC)

203CXC)

than 2400 m (8000 ft) above sea level at humid­ity between 30% and 75%

9 Medtronic limited warranty

For complete warranty information, see the accompanying limited warranty document.

10 Service

Medtronic employs highly trained representatives and engineers located throughout the world to
serve you and, upon request, to provide training to qualified hospital personnel in the use of
Medtronic products. Medtronic also maintains a professional staff to provide technical
consultation to product users. For more information, contact your local Medtronic representative,
or call or write Medtronic at the appropriate telephone number or address listed on the back cover.

6

Medtronic, Inc.

*M015861C001*

710 Medtronic Parkway

Minneapolis, MN 55432

USA

www.medtronic.com

[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: [phone]
Tachycardia: [phone]

Technical manuals

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© 2022 Medtronic

M015861C001 B
2022-03-21