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

Model Number	FGS-7000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician stated that he did not believe the perforation was device-related, and that perforation is a known complication of endometrial ablation.A follow-up report will be filed when the device is returned and the investigation can be completed.
Event or Problem Description
A patient with a uterine sound length of 8.5 cm and uterine cavity length of 4.5 cm was treated with the cerene cryotherapy device.The device was inserted into the patient, after which the doctor set the device to the cavity length and confirmed placement of the device at the fundus.After attempting to inflate, the device displayed "possible perforation." the device was removed, and the physician decided to use a second device with the same lot number.Upon insertion, the physician noted that the device passed far enough that the sheath marking showing at the external os was 12 cm.The physician removed the device and performed hysteroscopy.Cavity visualization was not achieved, as the physician was unable to maintain fluid pressure, indicating a perforation.The patient was kept for observation for a few hours post-procedure and sent home with antibiotics expectantly.Follow-up with the patient at home several hours later indicated that she was doing fine.The patient returned to the office four days later and was reported to be doing fine.
Additional Manufacturer Narrative
Based on the details in the complaint report and analysis of the returned device, the root cause of the "possible perforation" fault appears to have been the device correctly detecting a uterine perforation, which is a known complication of endometrial ablation.

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 20242207
• Report Number: 3012018285-2024-00021
• Device Sequence Number: 8043303
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)241218(10)104808353
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2024
• Device Model Number: FGS-7000
• Device Lot Number: 104808353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female