Class 2 Device Recall Cerene Cryotherapy Device

• Date Initiated by Firm: March 20, 2025
• Date Posted: April 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1584-2025
• Recall Event ID: 96485
• PMA Number: P180032
• Product Classification: Device, thermal ablation, endometrial - Product Code MNB
• Product: Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A
• Code Information: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874
• Recalling Firm/ Manufacturer: Channel Medsystems, Inc.; 2919 7th St; Berkeley CA 94710-2704
• Manufacturer Reason for Recall: Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
• FDA Determined Cause: Under Investigation by firm
• Action: On 03/20/2025, the firm emailed customer an "URGENT MEDICAL DEVICE CORRECTION" Letter informing them that the evaporator gasket inside the handle of the device may not seal properly, which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device. Customers are instructed to: 1. Check your internal inventory to determine if you have any affected devices. 2. Stop use of affected devices. 3. Vent the affected devices by following the attached instructions and then discard the devices according to your facility s procedures. 4. Complete and return the customer acknowledgement form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete the form even if you no longer have any of the affected devices in your physical inventory. 5. Circulate this letter to all other relevant parties, as needed. For questions, contact Channel Medsystems at safetynotice@cerene.com or at (510)338-9301 Monday thru Friday 8:00 AM to 5:00 PM Pacific Time
• Quantity in Commerce: 281
• Distribution: U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MNB