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

Model Number	FGS-7000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
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 390 is "uterus partially treated, end procedure, do not re-treat." no injury or adverse events were reported.Device was discarded and not available for testing.
Event or Problem Description
The cerene cryotherapy device reported error code 390 during the delivery of cryoablation.The physican was uncertain whether she had retracted the device to the uterine cavity length and may have inadvertently pressed the button too many times, pausing the device (which ultimately timed out).The physician elected to open a second device, the procedure was completed, and the patient was successfully treated.
Additional Manufacturer Narrative
As the device was not returned, the investigation conclusion of user error was based on the complaint report, which stated that the user paused and stopped the device as they were unsure if the cavity retraction step had been performed correctly.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 390 is "uterus partially treated, end procedure, do not re-treat." no injury or adverse events were reported.

• 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: 20453432
• Report Number: 3012018285-2024-00023
• Device Sequence Number: 7032081
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)241114(10)104521904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/21/2024

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
• Device Expiration Date: 11/14/2024
• Device Model Number: FGS-7000
• Device Lot Number: 104521904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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