MAUDE Adverse Event Report: CHANNEL MEDSYSTEMS CERENE CRYOTHERAPY DEVICE; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	FGS-7000
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Any device malfunction during treatment can potentially lead to a user electing to perform a repeat endometrial ablation, which can pose a serious risk to health.Labeling for the cerene cryotherapy device states that the "treatment status and next steps" for error code 379 is "uterus partially treated, end procedure, do not re-treat." though it was noted that a repeat endometrial ablation was performed, no injury or adverse events were reported.
Event or Problem Description
The physician inserted the device, which passed all safety checks and began treatment.14 seconds into treatment, the device stopped and flashed error code 379.The physician removed the device and began venting it.The physician then proceeded with a new device and completed a full treatment on the patient.The patient was discharged and no adverse events or injury were reported.Based on evaluation of the returned device, the root cause for the malfunction was tearing in the silicone pressure sleeve during manufacturing.Process updates have since been implemented to help prevent this failure mode.

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): CHANNEL MEDSYSTEMS; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 19283497
• Report Number: 3012018285-2024-00013
• Device Sequence Number: 15527471
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)240103(10)93355927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2024
• Device Model Number: FGS-7000
• Device Lot Number: 93355927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female