BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 23408046 · Received October 28, 2025

    Report

    Report Number
    3012018285-2025-00009
    Event Type
    Injury
    Date Received
    October 28, 2025
    Report Date
    November 26, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPANY REPRESENTATIVE MADE THREE ATTEMPTS TO CONTACT THE PHYSICIAN VIA PHONE AND/OR EMAIL TO COLLECTION ADDITIONAL INFORMATION, HOWEVER THE PHYSICIAN COULD NOT BE REACHED. HEMATOMETRA IS A KNOWN ADVERSE EVENT AND IS DOCUMENTED IN THE IFU FOR THE CERENE CRYOTHERAPY DEVICE AS AN ADVERSE EVENT THAT "COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF OTHER ENDOMETRIAL ABLATION SYSTEMS AND MAY OCCUR WHEN THE CERENE DEVICE IS USED:."

    Additional Manufacturer Narrative · 0

    PREFERRED TERM FOR HEALTH EFFECTS - ANNEX E WOULD BE "HEMATOMETRA." DEVICE WAS DISCARDED AT THE TIME OF TREATMENT, THEREFORE NO DEVICE EVALUATION CAN BE PERFORMED. INVESTIGATION VIA COMMUNICATION/INTERVIEWS IS ONGOING.

    Description of Event or Problem · 0

    IN RESPONSE TO AN EMAIL FROM A COMPANY REPRESENTATIVE, A PHYSICIAN REPORTED THAT A PATIENT HE HAD TREATED WITH THE CERENE CRYOTHERAPY DEVICE HAD DEVELOPED HEMATOMETRA THAT HAD TO BE EVACUATED AFTER SOME UNKNOWN TIME POST-PROCEDURE. IN ADDITIONAL CORRESPONDENCE WITH COMPANY REPRESENTATIVES WHO WERE PRESENT ON THE DAY OF THE PROCEDURE, IT WAS NOTED THAT THE ENDOMETRIAL CRYOABLATION WITH THE CERENE DEVICE MAY HAVE BEEN PERFORMED CONCOMITANTLY WITH A FIBROID REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254515 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 112041066 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention